Disclaimer: This consolidation is not an official copy of the law because it is affected by one or more retroactive provisions which have not been incorporated into it. For information about the retroactive provisions, see O. Reg. 55/06, subsection 5 (2).

“extemporaneous preparation” means a drug or combination of drugs prepared or compounded in a pharmacy according to a prescription;

“Formulary” means the Ministry of Health and Long-Term Care publication titled “Drug Benefit Formulary/Comparative Drug Index” (No. 38) dated January 30, 2003, and includes the following amendments to the publication:

1. Amendments dated April 16, 2003.

2. Amendments dated September 4, 2003.

3. Amendments dated April 6, 2004.

4. Amendments dated July 20, 2004.

5. Amendments dated November 4, 2004.

6. Amendments dated February 22, 2005.

7. Amendments dated May 25, 2005;

“Ministry” means the Ministry of Health;

“modified release dosage form” means a dosage form of a product that is formulated to control the level of the drug in the blood over a shorter or longer period of time than a conventional dosage form;

“spouse” means a person,

(a) to whom the person is married, or

(b) with whom the person is living in a conjugal relationship outside marriage, if the two persons,

(i) have cohabited for at least one year,

(ii) are together the parents of a child, or

(iii) have together entered into a cohabitation agreement under section 53 of the Family Law Act;

(2) For the purposes of this Regulation, Items 1208 and 1209 of Part III of the Formulary shall be deemed to have been revoked. O. Reg. 324/00, s. 1.

(3) For the purposes of this Regulation, items 255 and 256 of Part III of the Formulary are deemed to read as follows:

255

5mg Tab

4.5900

02232043

Aricept

PFI

4.5900

256

10mg Tab

4.5900

02232044

Aricept

PFI

4.5900

Reason for Use Code

Clinical criteria

347

For the initial trial for patients with mild to moderate Alzheimer’s disease (Mini-Mental State Exam [MMSE] 10-26), patients will be reimbursed for a period of up to three months after which continued treatment must be reassessed.

348

For continuation of therapy, further reimbursement will be made available to those patients whose disease has not progressed or deteriorated while on this drug. Patients must continue to have a MMSE score of 10-26.

O. Reg. 172/01, s. 1 (2).

(4) For the purposes of this Regulation, items 301 and 309 of Part III of the Formulary shall be deemed to have been revoked and item 309 shall be deemed to read as follows:

SALBUTAMOL 4.6400

309

100mcg/Met Dose Inh-200 dose Pk

00790419

Apo-Salvent (Not a Benefit)

APX

00851841

Salbutamol Inhaler (Not a benefit)

KNR

00874086

Novo-Salmol (Not a benefit)

NOP

02213478

Ventolin (Not a benefit)

GLW

02232570

Airomir HFA

MMH

4.6500

02244914

Ratio-Salbutamol HFA

RAI

4.6400

02245669

+Apo-Salvent CFC Free

APX

4.6400

O. Reg. 375/02, s. 1.

(5) For the purposes of this Regulation, the reference in Part III of the Formulary to 02244914 Alti-Salbutamol HFA 100mcg/MET Dose Inh-200 Dose Pk SALBUTAMOL SULFATE ALT 4.64 shall be read as if it did not exist. O. Reg. 375/02, s. 1.

(6) For the purposes of this Regulation, items 693 and 694 of Part III of the Formulary shall be deemed to have been revoked. O. Reg. 318/04, s. 1.

Eligible Persons

2. (1) Subject to subsections (2) and (3), the following classes of persons who are insured persons under the Health Insurance Act are designated as eligible classes of persons for the purposes of section 2 of the Act:

1. Persons who are receiving home care services within the meaning of home care services in subsection 13 (1) of Regulation 552 of the Revised Regulations of Ontario, 1990 (General) for which payment is made under the Health Insurance Act.

2. Persons who reside in homes licensed under section 5 of the Homes for Special Care Act.

3. Persons who are eligible for a pension under Part I of the Old Age Security Act
(Canada).

4. Persons who have attained 65 years of age.

5. Residents of approved charitable homes for the aged under the Charitable Institutions Act.

6. Residents of homes under the Homes for the Aged and Rest Homes Act.

(2) A person is not a member of the class of persons referred to in paragraph 3 of subsection (1) until the first day of the month for which the person first receives payment of the pension. O. Reg. 201/96, s. 2 (2).

(3) A person is not a member of the class of persons referred to in paragraph 4 of subsection (1) until the latest of,

(a) the first day of the month following the month the person attains 65 years of age;

(b) the day that is five years earlier than the day the Minister receives all the information required by the Minister to confirm that the person has attained 65 years of age and that the person has been an insured person under the Health Insurance Act
since the beginning of the five-year period; and

(c) the day the person becomes an insured person under the Health Insurance Act. O. Reg. 201/96, s. 2 (3).

Trillium Program

3. (0.1) In this section and in sections 4, 4.1 and 4.2,

“fiscal period” means the 12-month period that begins on August 1 of every year and ends on the following July 31;

“quarter” means, in relation to a fiscal period, a three-month period that begins on August 1, November 1, February 1 or May 1. O. Reg. 374/99, s. 1 (1).

(1) In addition to the classes listed in subsection 2 (1), persons who meet the following qualifications are designated as an eligible class of persons for the purposes of section 2 of the Act:

1. A person must be an insured person under the Health Insurance Act.

2. A person must be a member of a household unit whose members have collectively spent, in any quarter of a fiscal period, the amount determined in sections 4, 4.1 and 4.2, or more, on allowable expenses.

3. In order to become eligible, an application to become enrolledmust be made to the Minister on behalf of the person’s household unit and the Minister must be satisfied that the members of the household unit have collectively spent the amount determined in accordance with sections 4, 4.1 and 4.2, or more, on allowable expenses in any quarter in a fiscal period. O. Reg. 201/96, s. 3 (1); O. Reg. 83/98, s. 1 (2); O. Reg. 374/99, s. 1 (2); O. Reg. 69/00, s. 2 (1, 2); O. Reg. 156/05, s. 1 (1).

(2) A person becomes a member of the class of eligible persons referred to in subsection (1) after the beginning of each quarter of a fiscal period only once the members of his or her household unit have spent the amount determined under sections 4, 4.1 and 4.2 on allowable expenses and the person ceases to be a member of the class at the end of the quarter. O. Reg. 374/99, s. 1 (3); O. Reg. 69/00, s. 2 (3).

(3) Subject to subsection (3.1), an application under paragraph 3 of subsection (1) shall be made in the form provided by the Minister and must include,

(a) receipts for allowable expenses as required by the form;

(b) information evidencing annual net income as required by the form; and

(3.1) Every application made under paragraph 3 of subsection (1) shall be deemed to be renewed every year, effective as of the first day of the fiscal period, unless,

(a) the Minister confirms that no claims for payment were submitted to the Health Network mentioned in section 23 on behalf of any member of the household unit for one fiscal period;

(b) the member of the household unit that made the application on behalf of the household unit notifies the Minister that all members of the household unit withdraw the general consent required by the application form; or

(c) the member of the household unit that made the application requests that the Minister terminate the enrolment of all members of the household unit. O. Reg. 156/05, s. 1 (2).

(3.2) If a person’s application is not renewed for one of the reasons set out in subsection (3.1), the person may reapply to be enrolled by completing the application form required by paragraph 3 of subsection (1) in accordance with subsection (3). O. Reg. 156/05, s. 1 (2).

(3.3) The member of the household unit that made the application shall notify the Minister in writing of any change in the unit’s circumstances or membership that results in a member of the household unit ceasing to be a member of the eligible class of persons, or of any other changes that may affect the calculation of the unit’s allowable expenses under section 4, 4.1 or 4.2. O. Reg. 156/05, s. 1 (2).

(4) Subject to subsections (6), (8) and (9), the following expenses are allowable expenses for the purposes of paragraph 2 of subsection (1):

1. The cost, including the dispensing fee, of the following products that are to be used by a member of the household unit other than a member who is an eligible person:

i. A listed drug product, subject to subsection (4.1).

ii. A product listed in Part VI of the Formulary.

iii. A listed substance.

iv. A drug listed in Schedule F or G of the Food and Drugs Act (Canada) that meets the criteria set out in subsection (5).

v. A nutritional product or a diabetic testing agent that is funded under the Ontario Drug Benefit Program.

vi. An extemporaneous preparation that is a designated pharmaceutical product under paragraph 2 of subsection 9 (1).

vii. A product listed in Schedule 2.

viii. A product to which the Act has been made to apply, under section 8 of the Act, in respect of the supply of the product for a member of the household unit.

2. A co-payment paid upon the purchase of a product that is referred to in paragraph 1 and is to be used by a member of the household unit who, at the time the product is purchased, is an eligible person.

3. An insurance premium paid to insure a member of the household unit against the cost of any products referred to in paragraph 1, up to a maximum premium of,

(4.1) A listed drug product for which clinical criteria are specified under section 23 of the Act shall not be an allowable expense unless the product is supplied in circumstances that meet the clinical criteria. O. Reg. 336/96, s. 2 (2).

(5) For the purposes of subparagraph iv of paragraph 1 of subsection (4), the cost of a drug referred to in subparagraph iv of paragraph 1 of subsection 3 (4) is an allowable expense if,

(a) the Minister has been informed by a physician that the proper treatment of the patient requires the administration of the drug; and

(b) the Director of the Drug Programs Branch of the Ministry, on the advice of a panel of experts appointed for this purpose, recommends the use of the drug based on clinical criteria that relate to the patient’s case. O. Reg. 201/96, s. 3 (5); O. Reg. 507/96, s. 1 (2); O. Reg. 508/96, s. 2 (3).

(6) The cost of a product referred to in paragraph 1 of subsection (4) shall not be an allowable expense if,

(a) the product was not prescribed by a member of a health profession acting within the scope of his or her practice; or

(b) the product is for use by a member of the household unit who, at the time the product is purchased, is not an insured person under the Health Insurance Act. O. Reg. 201/96, s. 3 (6); O. Reg. 69/00, s. 2 (7).

(8) If the cost of a product referred to in paragraph 1 of subsection (4) or part of the cost of that product, has been, or may be, reimbursed under the Ontario Health Insurance Plan or under an insurance plan or by an employer or a third party acting on behalf of an employer, the cost or part of that cost that may be reimbursed shall not be an allowable expense. O. Reg. 73/04, s. 1.

(9) An insurance premium shall not be an allowable expense if,

(a) the premium is to insure a member of the household unit who is an eligible person or who is not an insured person under the Health Insurance Act; or

(2) Subject to subsections (4) and (5), a household unit’s annual net income shall be determined based on each member’s annual net income for his or her most recent taxation year. O. Reg. 83/98, s. 2 (1); O. Reg. 69/00, s. 3 (2).

(3) For the purposes of this section, a member’s most recent taxation year is the member’s taxation year that ended before the beginning of the fiscal period in respect of which an application is made under paragraph 3 of subsection 3 (1) or renewed under subsection 3 (3.1). O. Reg. 156/05, s. 2 (1).

(4) For the fiscal period that begins on April 1, 1997 and ends on July 31, 1998, the members of a household unit may elect to determine the household unit’s annual net income based on each member’s annual net income for the taxation year immediately preceding the members’ most recent taxation year. O. Reg. 83/98, s. 2 (1); O. Reg. 69/00, s. 3 (3).

(5) The members of a household unit may elect to determine the household unit’s annual net income based on each member’s annual net income for the taxation year immediately following the members’ most recent taxation year if the election would result in a difference of 10 per cent or more in the unit’s annual net income. O. Reg. 83/98, s. 2 (1); O. Reg. 69/00, s. 3 (4).

(6) In the case of an election under subsection (5), if the relevant taxation year of a member of a household unit is not complete on the day the application to be enrolled is made or the day upon which the Minister receives the member’s written notification of his or her election, whichever is later, the member’s annual net income for that taxation year shall be determined using the sum of,

(a) the member’s income from the beginning of the taxation year until the day of the application or the Minister’s receipt of the notification of election; and

(b) an estimate of the member’s income from the day of the application or the Minister’s receipt of the notification of election until the end of the taxation year. O. Reg. 156/05, s. 2 (2).

(7) An estimate under clause (6) (b) shall be determined by multiplying the number of days remaining in the member’s taxation year by the member’s average daily income for the month immediately preceding the day of the application or receipt of notification. O. Reg. 156/05, s. 2 (2).

(8) Revoked: O. Reg. 83/98, s. 2 (3).

(9) In this section,

“annual net income” means the amount indicated on line 236 of the Notice of Assessment issued under the Income Tax Act (Canada) for the relevant taxation year or, if no Notice of Assessment has been issued, the amount that would appear on that line had the Notice of Assessment been issued;

“relevant taxation year” means, with respect to a person, the person’s most recent taxation year, or such other taxation year, as may be determined in accordance with subsections (2), (3) and (4). O. Reg. 83/98, s. 2 (4).

4.1 (1) The amount referred to in paragraphs 2 and 3 of subsection 3 (1) as determined under subsection 4 (1) shall be increased in accordance with subsection (2) if,

(a) the amount is being determined with respect to the second, third or fourth quarter of a fiscal period; and

(b) in the quarter immediately preceding the quarter in respect of which eligibility is being determined, the members of the person’s household unit spent less on allowable expenses than the amount determined under subsection 4 (1). O. Reg. 374/99, s. 3; O. Reg. 69/00, s. 4 (1); O. Reg. 156/05, s. 3.

(2) The amount of the increase under subsection (1) shall be determined in accordance with the following formula:

where,

A is the amount of the increase,

B is the amount determined under subsection 4 (1) that the members of the person’s household unit are required to have collectively spent on allowable expenses in order to be part of the eligible class of persons referred to in subsection 3 (1), and

C is the amount that the members of the person’s household unit actually spent on allowable expenses in the previous quarter of the fiscal period.

O. Reg. 374/99, s. 3; O. Reg. 69/00, s. 4 (2).

4.2 (1) If the application made under paragraph 3 of subsection 3 (1) in any given fiscal period requests that eligibility begin after the beginning of the period, the amount referred to in paragraphs 2 and 3 of subsection 3 (1) that must be spent on allowable expenses in each remaining quarter of the fiscal period shall be determined in accordance with subsection (2). O. Reg. 156/05, s. 4.

(2) The amount referred to in paragraphs 2 and 3 of subsection 3 (1) shall be determined in accordance with the following formula:

where,

A is the amount that the members of the person’s household unit must have collectively spent on allowable expenses where subsection (1) applies,

B is the amount determined under subsection 4 (1),

C is the number of days from the day eligibility begins to the end of the fiscal period, and

D is the total number of days in the fiscal period.

O. Reg. 374/99, s. 3; O. Reg. 69/00, s. 5.

5. (1) For the purposes of sections 3 and 4, two persons are members of the same household unit if,

(a) they are spouses of each other;

(b) they share a residence and,

(i) one is a parent, grandparent or other ancestor of the other or the legal guardian of the other, and

(ii) one is dependent for support, either wholly or partly, on the other; or

(c) they are each members of the same household unit with a third person under clause (a) or (b). O. Reg. 201/96, s. 5 (1); O. Reg. 69/00, s. 6 (1-3); O. Reg. 334/05, s. 2 (1).

(2) Revoked: O. Reg. 69/00, s. 6 (4).

(3) Revoked: O. Reg. 69/00, s. 6 (4).

(4) For the purposes of this section, spouses who cease to live together because of a breakdown in their marriage or relationship are not members of the same household unit. O. Reg. 69/00, s. 6 (5); O. Reg. 334/05, s. 2 (2).

(5) Despite clause (1) (b), a person is a member of the same household unit as a parent, grandparent or other ancestor or is a member of the same household unit as his or her legal guardian even if they do not share a residence so long as the person,

(a) is a student;

(b) is dependent for support, either wholly or partly, on the parent, grandparent, ancestor or legal guardian; and

(c) elects to be part of the household unit of the parent, grandparent or other ancestor or legal guardian. O. Reg. 201/96, s. 5 (5); O. Reg. 69/00, s. 6 (6).

(6) A student shall not elect to be part of the household unit of a parent, grandparent or other ancestor or of a legal guardian under clause (5) (c) if,

(a) the student has elected to be part of the household unit of another parent, grandparent, ancestor or legal guardian upon whom the student is dependent for support, either wholly or partly; or

6. An individual who is not part of the same household unit as another person pursuant to section 5 shall constitute a household unit for the purposes of sections 3 and 4. O. Reg. 69/00, s. 7.

Designations

7. A drug product identified by brand name and manufacturer in Part III of the Formulary is designated as a listed drug product unless there is an indication in that Part that the drug product is not a benefit. O. Reg. 201/96, s. 7.

7.1 A drug product identified by brand name and manufacturer in the following amendments to Part III of the Formulary is designated as a listed drug product unless there is an indication in that Part that the drug product is not a benefit:

9. (1) For the purposes of subsection 17 (1) of the Act, the following products are designated as pharmaceutical products:

1. A substance that is identified as a “dpp” in Part III of the Formulary.

2. An extemporaneous preparation that is not equivalent to a manufactured drug product and meets one of the criteria set out in subsection (2). O. Reg. 201/96, s. 9 (1).

(2) An extemporaneous preparation referred to in paragraph 2 of subsection (1) is designated as a pharmaceutical product if,

(a) it is for internal consumption and contains a solid oral dosage form of a listed drug product and no other active substance;

(b) subject to subsection (3), it is for injection and is prepared by or under the direct supervision of a member of the Ontario College of Pharmacists who holds a certificate of registration as a pharmacist;

(c) it is for dermatological use and contains a listed drug product used for dermatological purposes and no other active substance other than one or more of the following:

(i) camphor,

(ii) compound benzoin tincture,

(iii) hydrocortisone powder,

(iv) liquor carbonis detergens,

(v) menthol,

(vi) salicylic acid,

(vii) sulfur, or

(viii) tar distillate; or

(d) it is one of the following:

(i) a topical nitrogen mustard preparation,

(ii) a topical preparation consisting of liquor carbonis detergens, salicylic acid, sulfur or tar distillate, but no other active substance, compounded in petrolatum jelly or lanolin,

(iii) an ophthalmic solution containing amikacin, cefazolin or vancomycin, or

(b) it contains one or more products listed in Parts III and XII of the Formulary, but the patient for whom the extemporaneous preparation is prescribed does not meet the criteria set out in the Formulary for the use of the component product or products; or

(c) it contains a product for which Health Canada provides a Notice of Compliance to the product’s manufacturer on or after September 4, 2003. O. Reg. 372/03, s. 1 (2); O. Reg. 12/05, s. 2.

10. A listed drug product that is identified as an “otc” in Part III of the Formulary is designated as a listed drug product that does not require a prescription for the purposes of clause 6 (2) (b) of the Act. O. Reg. 201/96, s. 10.

Conditions for Designation of Listed Drug Products

11. A strength and dosage form of a product that has been submitted for designation as an interchangeable product under the Drug Interchangeability and Dispensing Fee Act shall not be designated as a listed drug product unless the manufacturer submits the information required under section 12 and the following conditions are met:

1. If the original product is a listed product and there are no other interchangeable products already designated under the Drug Interchangeability and Dispensing Fee Act, the drug benefit price of the product proposed to the Minister under clause 12 (1) (d) must be less than or equal to 70 per cent of the drug benefit price, as set out in Part III of the Formulary, of the product with which it would be interchangeable.

2. If the original product is a listed product and there are other interchangeable products already designated under the Drug Interchangeability and Dispensing Fee Act, the drug benefit price of the product proposed to the Minister under clause 12 (1) (d) must be,

i. if the original product was listed as a listed drug product on or before March 31, 1994, less than or equal to the greater of the following amounts,

A. 63 per cent of the drug benefit price of the original product, as set out in the Formulary at the time the proposal is made to the Minister under clause 12 (1) (d), or

B. 63 per cent of the best available price of the original drug product, as set out in the Formulary on March 31, 1994, and

ii. if the original product was listed as a listed drug product after March 31, 1994, less than or equal to the greater of the following amounts:

A. 63 per cent of the best available price or drug benefit price, as the case may be, of the original product, as set out in the Formulary at the time the original product was listed, or

B. 63 per cent of the drug benefit price of the original product at the time the proposal is made to the Minister under clause 12 (1) (d),

but in no event shall the drug benefit price of the proposed product be greater than the highest drug benefit price among the drug benefit prices set out in the Formulary for the products with which the proposed product would be interchangeable.

3. If the product is an original product that was but is no longer a listed drug product and if there are no other interchangeable products already designated under the Drug Interchangeability and Dispensing Fee Act, the drug benefit price of the product proposed to the Minister under clause 12 (1) (d) must be,

i. less than or equal to 70 per cent of the drug benefit price of the original product that was set out in the Formulary immediately before its removal, or

ii. if the original product was removed from the Formulary as a listed drug product before May 27, 1996, less than or equal to 70 per cent of the best available price that was set out in the Formulary immediately before the removal of the original product.

4. If the product is an original product that was but is no longer a listed drug product and if there are other interchangeable products already designated under the Drug Interchangeability and Dispensing Fee Act, the drug benefit price of the product proposed to the Minister under clause 12 (1) (d) must be,

i. less than or equal to 63 per cent of the drug benefit price of the original product that was set out in the Formulary immediately before its removal, or

ii. if the original product was removed from the Formulary as a listed drug product before May 27, 1996, less than or equal to 63 per cent of the best available price that was set out in the Formulary immediately before the removal of the original product. O. Reg. 219/98, s. 1; O. Reg. 592/98, s. 1; O. Reg. 495/00, s. 1.

12. (1) A strength and dosage form of a drug product shall not be designated as a listed drug product unless the manufacturer of the drug product submits to the Minister,

(a) evidence that Health Canada has approved the product for sale in Canada, a copy of the product’s drug notification form issued by Health Canada and, subject to subsection (2), a copy of the product monograph approved by Health Canada;

(b) a
letter authorizing the Minister to gain access to all information with respect to the product in the possession of Health Canada, the Patented Medicine Prices Review Board established under section 91 of the Patent Act (Canada), the government of any province or territory in Canada or the Canadian Coordinating Office of Health Technology Assessment and authorizing the Minister to disclose any information with respect to the product in the possession of the Ministry to Health Canada, the Patented Medicine Prices Review Board, the government of a province or territory in Canada or the Canadian Coordinating Office of Health Technology Assessment;

(c) Revoked: O. Reg. 27/97, s. 1 (2).

(d) the proposed drug benefit price of the product;

(e) evidence that the manufacturer is able to supply the product at the proposed drug benefit price in a quantity sufficient to meet the anticipated demand for the product;

(f) Revoked: O. Reg. 27/97, s. 1 (3).

(g) Revoked: O. Reg. 27/97, s. 1 (3).

(h) clinical studies and, if available, other clinical evidence of the product’s therapeutic effectiveness or efficacy and of the product’s safety, including any information that relates to adverse drug reactions and any existing clinical studies comparing the product’s therapeutic effectiveness or efficacy and the product safety to that of other products or treatments; and

(2) If Health Canada has not approved a product monograph for a drug product, the manufacturer of the drug product may, instead of submitting a copy of the product monograph as required under clause (1) (a), submit to the Minister the following information:

1. Pharmaceutical information.

2. Information with respect to the product’s clinical pharmacology.

3. Information as to the product’s indications and clinical use.

4. A list of any contra-indications, warnings or precautions in the use of the product and of possible adverse reactions to its use.

5. A list of symptoms of an overdose of the product and information as to the treatment of an overdose.

6. Information with respect to the dosage and administration of the product.

(3) A manufacturer may satisfy the condition set out in clause (1) (h) for a strength of a drug product by submitting the clinical evidence referred to in clause (1) (h) for another strength of the same dosage form of the drug product, if the evidence is sufficient for the purposes of evaluating the therapeutic effectiveness or efficacy and the safety of both the strengths of the dosage form of the product. O. Reg. 201/96, s. 12 (3).

(3.1) A manufacturer may satisfy the condition set out in clause (1) (h) for a format of a drug product by submitting the clinical evidence referred to in clause (1) (h) for another format of the drug product, if the evidence is sufficient for the purposes of evaluating the therapeutic effectiveness or efficacy and safety of both the formats of the product. O. Reg. 495/00, s. 2 (4).

(4) A manufacturer may satisfy the condition set out in clause (1) (h) for a drug product by submitting to the Minister the clinical evidence referred to in clause (1) (h) with respect to another product and submitting evidence that satisfies the Minister that the two products are bioequivalent. O. Reg. 201/96, s. 12 (4); O. Reg. 495/00, s. 2 (5).

(5) Subsection (4) does not apply if the drug product that the manufacturer seeks to have designated is the drug product of a drug for which there exists a listed drug product. O. Reg. 201/96, s. 12 (5).

(6) Subsection (1) does not apply to a drug product that is designated as an interchangeable product under the Drug Interchangeability and Dispensing Fee Act. O. Reg. 201/96, s. 12 (6).

(7) Revoked: O. Reg. 27/97, s. 1 (4).

12.0.1 (1) In addition to the conditions referred to in sections 11 and 12, it is a condition for the designation of a strength and dosage form of a drug product on or after June 1, 1998 that the manufacturer of the product and the Minister enter into a written agreement which shall set out the net costs to the Province in the three-year period following the day the product is designated in relation to,

(a) the proposed drug product, if listed; or

(b) a group of listed drug products set out in the agreement which shall include the proposed drug product, if listed. O. Reg. 221/98, s. 1.

(2) Subsection (1) does not apply to a drug product that is designated as an interchangeable product under the Drug Interchangeability and Dispensing Fee Act. O. Reg. 495/00, s. 3.

Conditions to Continue to be a Designated Listed Drug Product

12.1 The following conditions must be met in order for a designated listed drug product to continue to be designated as a listed drug product:

1. The manufacturer of the product shall give the Minister notice of any change made to the product, including a formulation change, and of any change in the ownership of the manufacturer.

2. The product must be authorized for sale under the Food and Drugs Act (Canada).

3. The manufacturer of the product must continue to be able to supply the product at the drug benefit price in a quantity that is sufficient to meet the demand for the product.

4. In the case of a strength and dosage form of a drug product that is designated on or after June 1, 1998, the manufacturer of the product must continue to be a party to a written agreement which shall set out the net costs to the Province during subsequent three-year periods in relation to,

i. the listed drug product, or

ii. a group of listed drug products set out in the agreement which shall include the listed drug product. O. Reg. 27/97, s. 2; O. Reg. 221/98, s. 2.

Amounts Paid by Minister

13. (1) For the purposes of paragraph 2 of subsection 6 (1) of the Act, the drug benefit price of a listed drug product is the price set out opposite the listed drug product in Part III of the Formulary. O. Reg. 201/96, s. 13 (1).

(2) For the purposes of paragraph 3 of subsection 6 (1) of the Act, the mark up on the drug benefit price of a listed drug product is 10 per cent of the drug benefit price. O. Reg. 201/96, s. 13 (2).

(3) For the purposes of clause 6 (2) (a) of the Act, the dispensing fee the Minister shall pay to a pharmacy operated in a hospital approved as a public hospital under the Public Hospitals Act for dispensing a listed drug product for an eligible person is $3.03. O. Reg. 201/96, s. 13 (3); O. Reg. 74/99, s. 1 (1); O. Reg. 290/03, s. 1 (1).

14. (1) For the purposes of subsections 4 (5), 6 (3) and (4) of the Act, the acquisition cost of a listed drug product supplied for an eligible person is the amount calculated by,

(a) determining, in accordance with subsections (2) and (3), the amount payable by the operator of the pharmacy to the manufacturer or wholesaler of the listed drug product for a shipment or order of the product, a portion of which was supplied for the eligible person;

(b) dividing the amount determined under clause (a) by the number of units of the listed drug product purchased from the manufacturer or wholesaler; and

(c) multiplying the unit cost determined under clause (b) by the number of units of the product or drug supplied for the eligible person. O. Reg. 201/96, s. 14 (1).

(2) The amount payable referred to in clause (1) (a) shall be the full amount payable for a shipment or order of a listed drug product less,

(a) any amount charged for shipping and handling of the listed drug product;

(b) the amount of any price reduction, rebate, discount or refund, other than a discount of 2 per cent, or less, of the net price of the product given to the operator of the pharmacy for paying the manufacturer or wholesaler within 30 days of the sale of the product; and

(c) the value of any free goods or other benefit provided by the manufacturer or wholesaler to the operator of the pharmacy in respect of the purchase of the listed drug product. O. Reg. 201/96, s. 14 (2).

(3) If the operator of the pharmacy delays payment for a period of more than 120 days after the delivery of the listed drug product, the amount payable for a shipment or order of a listed drug product shall be reduced by 1.5 per cent of the net price of the product for each full month or portion thereof that payment is delayed. O. Reg. 201/96, s. 14 (3).

15. (1) The drug benefit price of a drug for which there is not a listed drug product and to which the Minister has made the Act apply under section 8 of the Act is,

(a) for a drug listed in Schedule 4, the price set out opposite the drug in that Schedule; and

(b) for a drug not listed in Schedule 4, the acquisition cost of the drug. O. Reg. 201/96, s. 15 (1).

(2) Section 14 applies, with necessary modifications, to the determination of the acquisition cost of a drug for the purposes of clause (1) (b). O. Reg. 201/96, s. 15 (2).

16. (1) The drug benefit price of a designated pharmaceutical product that is set out in Part III of the Formulary is the price indicated opposite the product in Part III of the Formulary. O. Reg. 201/96, s. 16 (1).

(2) The drug benefit price of a designated pharmaceutical product that is an extemporaneous preparation referred to in paragraph 2 of subsection 9 (1) is the sum of the following amounts:

1. The drug benefit price of any ingredient used in making the preparation that is a listed drug product.

2. The acquisition cost of any ingredient used in making the preparation that is not a listed drug product.

3. An amount that is equal to 50 cents per minute for each minute or portion thereof used to compound the preparation or such lesser amount as may be claimed by the operator of the pharmacy for the compounding of the preparation. O. Reg. 201/96, s. 16 (2).

(3) Section 14 applies, with necessary modifications, to the determination of the acquisition cost of an ingredient for the purposes of paragraph 2 of subsection (2). O. Reg. 201/96, s. 16 (3).

17. (1) The amount the Minister shall pay a physician under subsection 5 (3) of the Act is the amount calculated by adding the amounts determined under paragraphs 1, 2 and 3 and subtracting from that total the maximum co-payment that may be charged in respect of the supplying of a listed drug product for an eligible person:

1. The dispensing fee determined under subsection (2).

2. The drug benefit price set out opposite the listed drug product in Part III of the Formulary but, if there are other listed drug products that are interchangeable with the drug product, the drug benefit price shall be deemed to be the lowest of the drug benefit prices prescribed by the regulations for the drug product and the listed drug products that are interchangeable with it.

3. A mark up equal to 10 per cent of the drug benefit price. O. Reg. 201/96, s. 17 (1).

(3) Subsections 6 (3), (4) and (5) of the Act and sections 14, 15 and 16 of this Regulation apply with necessary modifications with respect to amounts payable by the Minister to physicians under subsection 5 (3) of the Act. O. Reg. 201/96, s. 17 (3).

Limits on Amounts Paid by Minister

18.(1) If an eligible person is entitled to receive drug benefits under the Ontario Works Act 1997, the Minister is only required to pay under the Act for the quantity of a listed drug product supplied for the person at one time that is sufficient for a 35-day course of treatment. O. Reg. 301/02, s. 1.

(2) If an eligible person will be leaving Ontario for a period of at least 100 consecutive days within six months after the day a listed drug product is supplied for the person, the Minister is only required to pay under the Act for the quantity of the product supplied for the person at one time that is sufficient for a 100-day course of treatment. O. Reg. 301/02, s. 1.

(3) The Minister is only required to pay under the Act for the quantity of a listed drug product supplied for an eligible person, other than a person mentioned in subsection (1) or (2), at one time that is sufficient for a 30-day course of treatment if the product supplied is a product other than insulin and if the product supplied has not been supplied for the person within the previous 12-month period. O. Reg. 301/02, s. 1.

(4) Despite subsection (3), the Minister is required to pay for the quantity of a listed drug product described in that subsection that is sufficient for a 100-day course of treatment if, in the opinion of the person dispensing the product, the person will not be able to obtain a further supply of the product at the end of a 30-day course of treatment. O. Reg. 301/02, s. 1.

(5) The Minister is only required to pay under the Act for the quantity of a listed drug product supplied for an eligible person, other than a person mentioned in subsection (1) or (2), at one time that is sufficient for a 100-day course of treatment if the listed drug product supplied is a product other than one mentioned in subsection (3). O. Reg. 301/02, s. 1.

(6) The following rule applies for the purposes of subsections (2), (4) and (5):

1. If a listed drug product is supplied for a person who is part of the eligible class of persons designated under section 3 and if, by supplying a 100-day course of treatment of the product, the last day of the course of treatment would be more than 30 days after the end of the period for which the person is eligible, the Minister is only required under the Act to pay for the quantity of the listed drug product sufficient for a course of treatment that ends 30 days after the end of the period for which the person is eligible. O. Reg. 301/02, s. 1.

19. (1) For the purposes of subsections 4 (6) and 6 (5) of the Act, the Minister shall not pay the amount determined under subsection 4 (5) of the Act in respect of a prescription that contains a direction that there be no substitutions unless,

(a) in the case of a written prescription,

(i) the prescription is accompanied by a form completed and signed by the prescriber in which the interchangeable product that caused the adverse reaction is identified, and

(ii) the direction is made by the prescriber writing “no sub” or “no substitutions” on the prescription; and

(b) in the case of an oral prescription, the prescriber satisfies the operator of the pharmacy or the dispensing physician that a form in which the interchangeable product that caused the adverse reaction is identified has been completed and signed by the prescriber and will be delivered to the operator of the pharmacy or the dispensing physician forthwith. O. Reg. 201/96, s. 19 (1).

(2) The form referred to in clauses (1) (a) and (b) is the Health Canada adverse drug reaction form and is available from Health Canada or from the Ministry. O. Reg. 201/96, s. 19 (2).

20. The Minister shall pay an amount in respect of the supplying of a listed drug product only if such clinical criteria as may be specified for the product in Part III of the Formulary are met. O. Reg. 201/96, s. 20.

Co-payment

20.1 For the purposes of subsection 6 (1) of the Act and subject to section 20.2, the maximum co-payment that the operator of a pharmacy may charge a person other than the Minister in respect of supplying a listed drug product for an eligible person is $2 or the operator’s usual and customary dispensing fee, whichever is less. O. Reg. 324/96, s. 2.

20.2 (1) If a listed drug product is supplied for an eligible person described in subsection (3), the maximum co-payment that the operator of a pharmacy may charge in respect of the supply of the drug product for that eligible person shall be determined in accordance with this section. O. Reg. 83/98, s. 3 (1).

(2) In this section,

“allowable drug costs” means the sum of,

(a) any amount spent on co-payments in respect of listed drug products supplied for an eligible person in the current fiscal period, and

(b) any amount spent in respect of nutritional products or diabetic testing agents supplied for the eligible person in the current fiscal period that, in the absence of the co-payment scheme applied in respect of those products and agents, would have been paid by the Ministry under Part IX of the Formulary;

“annual net income” means the amount indicated on line 236 of the Notice of Assessment issued under the Income Tax Act (Canada) for the relevant taxation year or, if no Notice of Assessment has been issued, the amount that would appear on that line had the Notice of Assessment been issued;

“fiscal period” means the period of July 15, 1996 to March 31, 1997, the period of April 1, 1997 to July 31, 1998 and each succeeding 12-month period that commences on August 1 of each year and ends on July 31 of the following year;

“relevant taxation year” means, with respect to a person, the person’s most recent taxation year, or such other taxation year, as may be determined in accordance with section 20.3. O. Reg. 83/98, s. 3 (1).

(3) This section applies with respect to eligible persons referred to in paragraph 4 of subsection 2 (1) who are not part of any other class of eligible persons under the Act. However, the section does not apply if,

(a) the eligible person,

(i) has an annual net income of less than $16,018 and is single, or is no longer cohabiting with his or her spouse because the spouse is a person mentioned in paragraph 2, 5, 6 or 7 of subsection 2 (1), or

(ii) cohabitswith a spouse and, together with his or her spouse, has an annual net income of less than $24,175; and

(5) The maximum co-payment that may be charged in respect of the supply of a listed drug product for an eligible person under this section during a fiscal period shall be determined in accordance with the following rules:

1. Until the eligible person’s allowable drug costs for the fiscal period reach the deductible amount, the maximum co-payment that may be charged shall be the amount equal to the full amount otherwise payable by the Minister under section 6 of the Act in respect of the supply of the drug product less,

i. if the drug product is supplied in a pharmacy operated in a hospital approved as a public hospital under the Public Hospitals Act, 17 cents,

ii. if the drug product does not require a prescription for sale and is designated under section 10 as one to which clause 6 (2) (b) of the Act applies, a nil amount,

iii. if the drug product is supplied by a physician whose office is within 20 kilometres of an accredited pharmacy, 19 cents,

iv. if the drug product is supplied by a physician whose office is more than 20 kilometres from an accredited pharmacy, 22 cents, and

v. in all other cases, the amount, if any, by which the dispensing fee exceeds $6.11.

2. Despite paragraph 1, if charging the maximum co-payment permitted under that paragraph would result in the eligible person’s allowable drug costs for the current fiscal period exceeding the deductible amount, the maximum co-payment that may be charged shall be the difference between the deductible amount and the amount of the eligible person’s allowable drug costs paid so far in the current fiscal period.

3. On or after the day the eligible person’s allowable drug costs for the fiscal period reach or exceed the deductible amount, the maximum co-payment that may be charged for the remainder of the fiscal period shall be,

i. if the drug product is supplied in a pharmacy operated in a hospital under the Public Hospital Act, $2.83,

ii. if the drug product does not require a prescription for sale and is designated under section 10 as one to which clause 6 (2) (b) of the Act applies, a nil amount,

iii. if the drug product is supplied by a physician whose office is within 20 kilometres of an accredited pharmacy, $4.05,

iv. if the drug product is supplied by a physician whose office is more than 20 kilometres from an accredited pharmacy, $4.83,

v. in all other cases, the lesser of $6.11 or the amount the operator of the pharmacy that supplied the drug product sets as its dispensing fee under subsection 6 (1) of the Drug Interchangeability and Dispensing Fee Act. O. Reg. 83/98, s. 3 (4); O. Reg. 74/99, s. 3.

(6) For the purposes of subsection (5), the deductible amount used to determine the maximum co-payment that may be charged for the supply of a listed drug product for an eligible person during any fiscal period shall be as follows:

1. For any fiscal period other than the fiscal period referred to in paragraph 2, $100.

2. For the fiscal period in which the person to whom this section applies becomes eligible under the Act, the amount determined in accordance with subsections (8), (9) and (10). O. Reg. 83/98, s. 3 (4).

(7) If a person becomes eligible under the Act during a fiscal period other than the fiscal period referred to in subsection (8), the deductible amount used under subsection (5) to determine the maximum co-payment that may be charged during the fiscal period for the supply of a listed drug product for that eligible person shall be the percentage of $100 that is equal to the result obtained by dividing the number of months in the fiscal period by the number of months during the fiscal period that the person is eligible. O. Reg. 83/98, s. 3 (4).

(8) If a person becomes eligible under the Act during the period of April 1, 1996 to March 31, 1997, the deductible amount used under subsection (5) to determine the maximum co-payment that may be charged during the fiscal period of July 15, 1996 to March 31, 1997 shall be the percentage of $100 that is equal to the result obtained by dividing the number of months in the period of April 1, 1996 and March 31, 1997 by the number of months during that period that the person is eligible. O. Reg. 83/98, s. 3 (4).

(9) Tables 1, 2 and 3 to this subsection set out the deductible amount determined in accordance with subsections (7) and (8) applicable to the following fiscal periods:

1. The deductible amount applicable for the fiscal period that begins on July 15, 1996 and ends on March 31, 1997 with respect to a person who becomes eligible under the Act between April 1, 1996 and March 31, 1997 is set out in Column 2 to Table 1 opposite the period during which the person becomes eligible set out in Column 1 to the Table.

2. The deductible amount applicable for the fiscal period that begins on April 1, 1997 and ends on July 31, 1998 with respect to a person who becomes eligible under the Act during that fiscal period is set out in Column 2 to Table 2 opposite the period during which the person becomes eligible set out in Column 1 to the Table.

3. The deductible amount applicable for any fiscal period that begins after the fiscal period referred to in paragraph 2 with respect to a person who becomes eligible under the Act during the fiscal period is set out in Column 2 to Table 3 opposite the period during which the person becomes eligible set out in Column 1 to the Table.

TABLE 1

Column 1

Column 2

Period in which person becomes eligible

Deductible Amount

On or before April 1, 1996

$100.00

On or after April 2, 1996 but before May 2, 1996

91.67

On or after May 2, 1996 but before June 2, 1996

83.33

On or after June 2, 1996 but before July 2, 1996

75.00

On or after July 2, 1996 but before August 2, 1996

66.67

On or after August 2, 1996 but before September 2, 1996

58.33

On or after September 2, 1996 but before October 2, 1996

50.00

On or after October 2, 1996 but before November 2, 1996

41.67

On or after November 2, 1996 but before December 2, 1996

33.33

On or after December 2, 1996 but before January 2, 1997

25.00

On or after January 2, 1997 but before February 2, 1997

16.67

On or after February 2, 1997 but before April 1, 1997

8.33

TABLE 2

Column 1

Column 2

Period in which person becomes eligible

Deductible Amount

On or before April 1, 1997

$100.00

On or after April 2, 1997 but before May 2, 1997

93.75

On or after May 2, 1997 but before June 2, 1997

87.50

On or after June 2, 1997 but before July 2, 1997

81.25

On or after July 2, 1997 but before August 2, 1997

75.00

On or after August 2, 1997 but before September 2, 1997

68.75

On or after September 2, 1997 but before October 2, 1997

62.50

On or after October 2, 1997 but before November 2, 1997

56.25

On or after November 2, 1997 but before December 2, 1997

50.00

On or after December 2, 1997 but before January 2, 1998

43.75

On or after January 2, 1998 but before February 2, 1998

37.50

On or after February 2, 1998 but before March 2, 1998

31.25

On or after March 2, 1998 but before April 2, 1998

25.00

On or after April 2, 1998 but before May 2, 1998

18.75

On or after May 2, 1998 but before June 2, 1998

12.50

On or after June 2, 1998 but before August 1, 1998

6.25

TABLE 3

Column 1

Column 2

Month in which person becomes eligible

Deductible Amount

On or before August 1

$100.00

On or after August 2 but before September 2

91.67

On or after September 2 but before October 2

83.33

On or after October 2 but before November 2

75.00

On or after November 2 but before December 2

66.67

On or after December 2 but before January 2

58.33

On or after January 2 but before February 2

50.00

On or after February 2 but before March 2

41.67

On or after March 2 but before April 2

33.33

On or after April 2 but before May 2

25.00

On or after May 2 but before June 2

16.67

On or after June 2 but before August 1

8.33

O. Reg. 83/98, s. 3 (4).

20.3 (1) The annual net income for an eligible person referred to in subclause 20.2 (3) (a) (i) shall be the annual net income for his or her most recent taxation year. O. Reg. 83/98, s. 4.

(2) The annual net income for a couple under subclause 20.2 (3) (a) (ii) shall be determined based on each person’s annual net income for his or her most recent taxation year. O. Reg. 83/98, s. 4.

(3) A person’s most recent taxation year is the person’s taxation year that ended before the beginning of the fiscal period during which the listed drug product is supplied. O. Reg. 83/98, s. 4.

(4) Despite subsections (1) and (2), an eligible person may elect, for the fiscal period that begins on April 1, 1997 and ends on July 31, 1998,

(a) if he or she is single, to have his or her annual net income be the annual net income for his or her taxation year immediately preceding his or her most recent taxation year; and

(b) if he or she has a spouse, to have the couple’s annual net income be the sum of both person’s annual net income for their taxation year immediately preceding their most recent taxation year. O. Reg. 83/98, s. 4; O. Reg. 69/00, s. 9 (1); O. Reg. 334/05, s. 4 (1).

(5) Despite subsection (1), an eligible person who is single may elect to have his or her annual net income determined based on his or her annual net income for the taxation year immediately following his or her most recent taxation year if the election would result in a difference of 10 per cent or more in the person’s annual net income. O. Reg. 83/98, s. 4.

(6) Despite subsection (2), an eligible person who has a spouse may elect to have their annual net income determined based on each person’s annual net income for the taxation year immediately following his or her most recent taxation year if the election would result in a difference of 10 per cent or more in the couple’s annual net income. O. Reg. 83/98, s. 4; O. Reg. 69/00, s. 9 (2); O. Reg. 334/05, s. 4 (2).

(7) Subsections 4 (6) and (7) apply to the determination of the annual net income of a person or couple who makes an election under subsection (5) or (6). O. Reg. 83/98, s. 4.

Amount Charged to Person Other Than Minister

21. (1) In addition to any amounts authorized in the Act, the operator of a pharmacy who supplies a listed drug product for an eligible person may charge, or accept payment from, a person other than the Minister in accordance with this section. O. Reg. 201/96, s. 21 (1).

(2) If the quantity of a listed drug product supplied at one time for an eligible person exceeds the maximum quantity for which the Minister may pay under section 18, the operator of the pharmacy that supplied the product may charge a person other than the Minister an amount in respect of the additional quantity supplied. O. Reg. 201/96, s. 21 (2).

(3) The operator of a pharmacy shall not charge an amount under subsection (2) unless,

(a) the operator explains to the person who purchases the listed drug product the reason for the charge; and

(b) the operator gives the person the choice of receiving the additional quantity of the product and paying for it or of receiving only the quantity of the product for which the Minister is required to pay under section 18. O. Reg. 201/96, s. 21 (3).

(4) An operator of a pharmacy who supplies a listed drug product for an eligible person may charge a person other than the Minister an amount equal to the amount otherwise payable by the Minister under subsection 5 (1) or (3) of the Act if the person elects to pay the amount and, before the product is supplied, the person is advised that, subject to any co-payment, the product is available free of charge. O. Reg. 201/96, s. 21 (4).

(5) If the premises from which the operator of a pharmacy dispenses drugs are not electronically connected to the Health Network and, as a result, the operator does not submit claims by direct electronic transmission in accordance with section 24, the operator may charge, or accept payment from, a person other than the Minister in respect of supplying a listed drug product for an eligible person in an amount equal to the amount that would have been payable by the Minister were the operator entitled to be paid under subsection 5 (4) of the Act. O. Reg. 324/96, s. 3.

(6) In subsection (5),

“Health Network” has the same meaning as in subsection 23 (1). O. Reg. 324/96, s. 3.

22. For the purposes of subsection 4 (2) of the Act, a physician may charge, or accept payment from, a person other than the Minister in such amounts as may be charged by the operator of a pharmacy under subsection 4 (3), (4) or (5) of the Act or under section 21 of this Regulation. O. Reg. 201/96, s. 22.

Miscellaneous

23. (1) In sections 24 to 30,

“claim reversal” means a claim submitted to the Minster to correct an error made in a claim for payment previously submitted under the Act;

“Health Network” means the electronic information retrieval system used by the Ministry to receive and process claims for payment under the Act;

“Manual” means the Ontario Drug Programs Reference Manual dated November 15, 1993, available from the Ministry of Health, as most recently amended on May 27, 1996. O. Reg. 201/96, s. 23 (1).

(2) For the purposes of sections 24 to 30, a claim for payment made under the Act does notinclude a claim reversal. O. Reg. 201/96, s. 23 (2).

24. (1) An operator of a pharmacy or a physician who submits a claim for payment from the Minister under the Act or a claim reversal shall submit the claim to the Minister by direct electronic transmission via the Health Network. O. Reg. 201/96, s. 24 (1).

(2) Despite subsection (1), the following claims may be submitted on paper:

1. A claim for payment that is submitted to the Minister more than seven days after the drug is supplied because proof that the drug is for an eligible person is not provided to the operator of the pharmacy or physician who supplied the drug until that time.

2. A claim reversal that is made more than seven days after the day the original claim to which the claim reversal relates was submitted.

3. A claim for payment requiring more than two codes, as set out in the Manual.

4. A claim for payment by the Minister in respect of supplying a listed drug product where the amount claimed is $10,000 or more.

5. A claim for payment for the supply of an extemporaneous preparation where the claim indicates that time spent on the compounding of the preparation was 100 minutes or more.

6. A claim for payment that could not be submitted by direct electronic transmission via the Health Network because of a failure in the Network between January 1, 2000 and February 15, 2000. O. Reg. 201/96, s. 24 (2); O. Reg. 324/96, s. 4; O. Reg. 574/99, s. 1.

25. (1) A claim for payment from the Minister under the Act shall contain the following information:

1. The bank identification number of the Ontario Drug Benefit Program, as assigned by the Canadian Payments Association.

2. The pharmacy claim standard version number used to transmit the claim.

3. The code for identifying the transaction as a claim for payment, as set out in the Manual.

4. The code for identifying the pharmacy’s or physician’s computer system, as set out in the Manual.

5. The code assigned by the software vendor to identify the version of the pharmacy’s or physician’s software.

6. The pharmacy identification code, as assigned by the Minister to the pharmacy or the physician.

7. A number assigned to the transaction by the operator of a pharmacy or the physician.

8. The prescription number recorded on the prescription for the listed product supplied by the person dispensing the product.

9. The drug identification number of the listed drug product supplied or, in the case of a product other than a listed drug product, the product identification number assigned by the Minister to the product supplied.

10. The Ontario drug benefit eligibility number together with any version code that may appear on the health card of the eligible person for whom the listed drug product was supplied.

11. The first and last names of the eligible person for whom the listed drug product was supplied.

12. The year, month and day on which the listed drug product was supplied.

13. The quantity of the listed drug product supplied.

14. The number of days of treatment contained in the prescription, as estimated by the operator of the pharmacy or the physician.

15. The drug benefit price or, if the acquisition cost of the drug is payable under the Act, the acquisition cost of the drug supplied.

16. The dispensing fee for supplying the drug and the mark up on the drug, if any.

17. The total amount claimed by the operator of the pharmacy or physician for the supplying of the drug.

18. Any other information that is necessary to process the amount payable on the claim. O. Reg. 201/96, s. 25 (1).

(2) A claim for payment by the Minister under the Act with respect to the supplying of an extemporaneous preparation for an eligible person shall include, in addition to the information required under subsection (1), the following information:

1. The drug benefit price or, if the acquisition cost of the ingredient is payable under the Act, the acquisition cost of each ingredient and the total costs of all the ingredients.

2. The length of time in minutes that was spent compounding the ingredients, not including the time required to dispense the preparation and the amount claimed for the time spent compounding the preparation.

3. The product identification number assigned by the Minister to the extemporaneous preparation or, if there is no product identification number,

i. the drug identification number of the ingredient used in the preparation that has the highest cost, and

ii. the unlisted compound code assigned by the Minister to the preparation, as set out in the Manual. O. Reg. 201/96, s. 25 (2).

(3) If an operator of a pharmacy or a physician makes a claim for payment of the acquisition cost of a listed drug product under subsection 6 (3) of the Act, the claim for payment with respect to the supplying of the listed drug product shall include, in addition to the information required under subsection (1), the following information:

1. A calculation of the acquisition cost of the listed drug product in accordance with section 14.

2. The code for identifying the claim as being one to which subsection 6 (3) of the Act applies, as set out in the Manual.

3. Any other information that is necessary to calculate the cost to the operator of the pharmacy or the physician of the listed drug product. O. Reg. 201/96, s. 25 (3).

(4) If an operator of a pharmacy or a physician makes a claim for payment under the Act with respect to the supplying of a drug to which the Minister has made the Act apply under section 8 of the Act, the claim shall include, in addition to the information required under subsection (1), the following information:

1. A calculation of the acquisition cost of the drug in accordance with section 14, or if the drug is one that is referred to in Schedule 4, the drug benefit price of the drug.

2. The drug supply number provided by the Minister.

3. Any other information that is necessary to calculate the cost to the operator of the pharmacy or the physician of the drug. O. Reg. 201/96, s. 25 (4).

(5) If the operator of a pharmacy or a physician makes a claim for payment under the Act with respect to the supplying of a listed drug product pursuant to a prescription that contains a direction that there be no substitutions, the claim shall include, in addition to the information required under subsection (1), the following information:

1. The code for identifying the claim as being one to which subsection 6 (5) of the Act applies, as set out in the Manual.

2. Any other information that is necessary to calculate the cost to the operator of the pharmacy or the physician of the listed drug product. O. Reg. 201/96, s. 25 (5).

(6) If the operator of a pharmacy or a physician makes a claim for payment on paper under subsection 24 (2), the claim shall be submitted on a form that is provided by the Ministry and is completed and signed by the operator of a pharmacy or by the physician, as the case may be, and shall include all the information required under subsection (1) other than the information referred to in paragraphs 1, 2, 4, 5 and 7 of that subsection and shall include the information required under subsections (2), (3), (4) and (5), if applicable. O. Reg. 201/96, s. 25 (6).

26. (1) In a claim reversal, the operator of a pharmacy or physician shall include the following information:

1. The code used to identify the claim as a claim reversal, as set out in the Manual.

2. The pharmacy claim standard version number used to transmit the claim, as set out in the Manual.

(3) If, after a claim for payment of the acquisition cost of a listed drug product under subsection 6 (3) of the Act is submitted, the acquisition cost of the listed drug product is varied as a result of a price reduction given to the operator of the pharmacy or the physician in respect of the listed drug product, the claim reversal submitted by the operator of the pharmacy or the physician, as the case may be, shall include, in addition to the information required under subsection (1), a revised calculation of the cost of the listed drug product to the Minister forthwith. O. Reg. 201/96, s. 26 (3).

27. For the purposes of sections 11.1 and 11.2 of the Act, the Minister may make an order suspending an operator of a pharmacy or a physician from being entitled to receive payment from the Minister under the Act if the operator of the pharmacy or the physician, as the case may be, has breached one of the following conditions:

1. The operator of a pharmacy or the physician must be a party to a subscription agreement with the Ministry whereby the operator or physician agrees to have the premises from which he or she dispenses drugs connected electronically to the Health Network and to submit all claims for payment under the Act via the Health Network.

2. The operator of a pharmacy or a physician must not have been found guilty of a criminal offence related to fraud in the operation of the pharmacy or, in the case of a physician, in the practice of medicine. O. Reg. 201/96, s. 27.

28. (1) An eligible person who is entitled to be paid by the Minister under section 11.3 of the Act shall submit a claim for payment by the Minister on paper. O. Reg. 201/96, s. 28 (1).

(2) An eligible person who submits a claim under section 11.3 of the Act shall include the following information in the claim:

28.1 (1) If the operator of a pharmacy charges a person other than the Minister an amount under subsection 21 (5) in respect of supplying a listed drug product, the eligible person for whom the product was supplied is entitled to be paid by the Minister the amount that would have been paid to the operator of a pharmacy had the operator been entitled to payment under subsection 5 (4) of the Act. O. Reg. 324/96, s. 5.

(2) An eligible person who is entitled to be paid under subsection (1) may submit a claim for payment on paper and the claim shall include the information set out in subsection 28 (2). O. Reg. 324/96, s. 5.

(3) This section applies to an eligible person who submits a claim in respect of supplying a listed drug product for which a person was charged by a physician under section 22 in accordance with subsection 21 (5). O. Reg. 324/96, s. 5.

29. (1) Every operator of a pharmacy and physician shall retain the records set out in Column 1 of the Table to this subsection for a minimum of the period of time indicated opposite the record in Column 2 of the Table.

TABLE

Column 1

Column 2

A copy of a statement of daily transaction totals prepared each day.

A period of two years from the day on which the daily statement is prepared.

A copy of each summary remittance statement or reject statement received from the Minister.

A period of two years from the day on which the statement is received.

A copy of each claim for payment or claim reversal submitted to the Ministry, together with a record of the date on which the claim was submitted.

A period of two years from the day on which each claim is submitted.

The monthly Ontario drug benefit eligibility card or a copy of the card with respect to each eligible person for whom a drug is dispensed.

A period of two years from the day on which the first drug is dispensed for the eligible person.

Each prescription received that contains a direction that there be no substitution, as well as a copy of the Health Canada adverse drug reaction form received with the prescription.

A period of two years from the date on which the form was received.

A form provided by the Minister confirming that a drug supplied is only to be supplied if it meets the applicable clinical criteria set out in Part III of the Formulary.

A period of two years from the date on which the form was received.

For each extemporaneous preparation supplied for an eligible person, the formula of the preparation, set out in a manner that clearly indicates all the ingredients and the quantities of those ingredients, the cost of each ingredient and the compounding time.

A period of two years from the date on which the preparation was supplied.

In all cases where the acquisition cost of a drug is claimed, a copy of the supplier’s invoice and a detailed calculation in accordance with section 14 of the cost of purchasing the drug product.

A period of two years from the date on which the invoice is received.

O. Reg. 201/96, s. 29 (1).

(2) The records referred to in the Table to subsection (1) shall be kept in, or be readily available to,

(a) in the case of the operator of a pharmacy, the pharmacy or the dispensary of the pharmacy; or

(b) in the case of a physician, the dispensary of the physician. O. Reg. 201/96, s. 29 (2).

29.1 Despite the revocation of Regulation 868 of the Revised Regulations of Ontario, 1990 by Ontario Regulation 203/96 and despite sections 23 to 26, the operator of a pharmacy or the physician who enters into a subscription agreement with the Ministry before May 27, 1996 but who, as of that date, has not had the premises from which he or she dispenses drugs electronically connected to the Health Network may continue to make claims for payment on paper in accordance with section 9 of Regulation 868 of the Revised Regulations of Ontario, 1990 until July 15, 1996. O. Reg. 324/96, s. 6.

30.Omitted (provides for coming into force of provisions of this Regulation). O. Reg. 201/96, s. 30.

TABLE ANNUAL OUT-OF-POCKET EXPENSE TO BE EXCEEDED TO BECOME ELIGIBLE FOR TRILLIUM DRUG PROGRAM (in $500 increments)